CO5790166A1 - Forma cristalina delta de clorhidrato de ivabradina, su procedimiento de preparacion y composicines farmaceuticas que las contienen - Google Patents
Forma cristalina delta de clorhidrato de ivabradina, su procedimiento de preparacion y composicines farmaceuticas que las contienenInfo
- Publication number
- CO5790166A1 CO5790166A1 CO06101549A CO06101549A CO5790166A1 CO 5790166 A1 CO5790166 A1 CO 5790166A1 CO 06101549 A CO06101549 A CO 06101549A CO 06101549 A CO06101549 A CO 06101549A CO 5790166 A1 CO5790166 A1 CO 5790166A1
- Authority
- CO
- Colombia
- Prior art keywords
- expressed
- ivabradine hydrochloride
- crystalline form
- pharmaceutical compositions
- degrees
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D223/00—Heterocyclic compounds containing seven-membered rings having one nitrogen atom as the only ring hetero atom
- C07D223/14—Heterocyclic compounds containing seven-membered rings having one nitrogen atom as the only ring hetero atom condensed with carbocyclic rings or ring systems
- C07D223/16—Benzazepines; Hydrogenated benzazepines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Hospice & Palliative Care (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Other In-Based Heterocyclic Compounds (AREA)
- Saccharide Compounds (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
? Forma cristalina d del clorhidrato de ivabradina de fórmula (I): <EMI FILE="06101549_1" ID="1" IMF=JPEG HE=50 WI=50 >Caracterizada por su diagrama de difracción X en polvo. Más específicamente, la presente invención se refiere a la forma cristalina d del clorhidrato de ivabradina, caracterizada por el diagrama de difracción X sobre polvo siguiente, medido en un difractómetro PANalytical XAND#39Pert Pro con un detector XAND#39Celerator, y expresado en términos de posición de Iínea (ángulo de Bragg 2 theta, expresado en grados), de altura de línea (expresada en puntos), de superficie de Iínea (expresada en puntos x grados), de anchura de líneas a media altura ("FWHM" , expresa, en grados) y de distancia inter-retícular d (expresada en A). La invención se extiende igualmente a un procedimiento de preparación de la forma cristalina d del clorhidrato de ivabradina, caracterizado porque se precalienta acetonitrilo o una mezcla de acetonitrilo y agua, se añade el clorhidrato de ivabradina, se deja enfriar la solución obtenida a temperatura ambiente y se deja a esta temperatura, luego se recogen los cristales formados. La invención se extiende también a las composiciones farmacéuticas que incluyen como principio activo la forma cristalina d del clorhidrato de ivabradina junto con uno o varios excipientes inertes, no tóxicos y adecuados. Entre las composiciones farmacéuticas según la invención, se podrán citar más particularmente aquellas que son adecuadas para la administración oral, parenteral (intravenosa o subcutánea), nasal, los comprimidos simples o en grageas, los comprimidos sublingüales, las cápsulas, las tabletas, los supositorios, las cremas, las pomadas, los geles dérmicos, las preparaciones inyectables, las suspensiones bebibles.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0510352A FR2891826B1 (fr) | 2005-10-11 | 2005-10-11 | Forme cristalline 6 du chlorhydrate de l'ivabradine, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO5790166A1 true CO5790166A1 (es) | 2007-08-31 |
Family
ID=36589231
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO06101549A CO5790166A1 (es) | 2005-10-11 | 2006-10-09 | Forma cristalina delta de clorhidrato de ivabradina, su procedimiento de preparacion y composicines farmaceuticas que las contienen |
Country Status (30)
| Country | Link |
|---|---|
| US (3) | US7358240B2 (es) |
| EP (2) | EP1956005A1 (es) |
| JP (1) | JP2007112796A (es) |
| KR (1) | KR20070040311A (es) |
| CN (1) | CN1948292A (es) |
| AP (1) | AP2303A (es) |
| AR (1) | AR056572A1 (es) |
| AU (1) | AU2006228027B2 (es) |
| BR (1) | BRPI0604250A (es) |
| CA (1) | CA2564367C (es) |
| CO (1) | CO5790166A1 (es) |
| CR (1) | CR8645A (es) |
| EA (1) | EA010296B1 (es) |
| EC (1) | ECSP066915A (es) |
| FR (1) | FR2891826B1 (es) |
| GE (1) | GEP20094653B (es) |
| GT (1) | GT200600450A (es) |
| IL (1) | IL178544A (es) |
| MA (1) | MA28626B1 (es) |
| MX (1) | MXPA06011766A (es) |
| MY (1) | MY139508A (es) |
| NO (1) | NO20064596L (es) |
| NZ (1) | NZ550435A (es) |
| PE (1) | PE20070492A1 (es) |
| SA (1) | SA06270370B1 (es) |
| SG (1) | SG131858A1 (es) |
| TW (1) | TWI377946B (es) |
| UA (1) | UA90265C2 (es) |
| WO (1) | WO2007042656A1 (es) |
| ZA (1) | ZA200608403B (es) |
Families Citing this family (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2868777B1 (fr) * | 2004-04-13 | 2006-05-26 | Servier Lab | Nouveau procede de synthese de l'ivabradine et de ses sels d'addition a un acide pharmaceutiquement acceptable |
| FR2882555B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme cristalline gamma du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2882556B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme cristalline gamma d du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2882553B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme cristalline beta du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2882554B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme critalline beta d du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2891827B1 (fr) * | 2005-10-11 | 2007-12-28 | Servier Lab | Forme cristalline deltad du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| ATE544754T1 (de) * | 2006-11-30 | 2012-02-15 | Cadila Healthcare Ltd | Verfahren zur herstellung von ivabradinhydrochlorid |
| CN101353325B (zh) * | 2007-07-27 | 2011-11-09 | 上海优拓医药科技有限公司 | 稳定型盐酸伊伐布雷定结晶及其制备方法 |
| KR101478855B1 (ko) | 2007-05-30 | 2015-01-02 | 인드-스위프트 래버러토리즈 리미티드 | 이바브라딘 히드로클로라이드 및 그의 다형태의 제조방법 |
| ES2402765T3 (es) | 2008-12-22 | 2013-05-08 | Krka, D.D., Novo Mesto | Procedimiento de preparación de ivabradina |
| CN101774969B (zh) | 2009-01-13 | 2012-07-04 | 江苏恒瑞医药股份有限公司 | 硫酸伊伐布雷定及其i型结晶的制备方法 |
| EA201290772A1 (ru) | 2010-02-12 | 2013-02-28 | КРКА, д.д., НОВО МЕСТО | Новые формы ивабрадина гидрохлорида |
| HUP1000245A2 (en) | 2010-05-07 | 2011-11-28 | Richter Gedeon Nyrt | Industrial process for the production ivabradin salts |
| FR2961105B1 (fr) * | 2010-06-15 | 2013-02-08 | Servier Lab | Utilisation de l'association d'un inhibiteur du courant if sinusal et d'un inhibiteur de l'enzyme de conversion de l'angiotensine pour le traitement de l'insuffisance cardiaque |
| WO2012025940A1 (en) | 2010-08-25 | 2012-03-01 | Cadila Healthcare Limited | Polymorphic form of ivabradine hydrochloride and process for preparation thereof |
| US9440924B2 (en) | 2011-08-02 | 2016-09-13 | Sandoz Ag | Acetone solvate of ivabradine hydrochloride |
| EP2589594A1 (en) * | 2011-11-04 | 2013-05-08 | Urquima S.A. | Ivabradine hydrochloride Form IV |
| WO2013064427A1 (en) | 2011-11-04 | 2013-05-10 | Synthon Bv | A process for making crystalline delta-form of ivabradine hydrochloride |
| EP3156399A1 (en) * | 2011-11-14 | 2017-04-19 | Cadila Healthcare Limited | Polymorphic forms of ivabradine hydrochloride |
| EP2948432B1 (en) | 2013-01-24 | 2018-09-19 | Synthon BV | Process for making ivabradine |
| EP2781509B2 (en) | 2013-03-19 | 2023-06-14 | Chemo Research, S.L. | New polymorph of ivabradine hydrochloride and method for its preparation |
| CZ305096B6 (cs) | 2013-10-02 | 2015-04-29 | Zentiva, K.S. | Pevná forma Ivabradin hydrochloridu a (S)-mandlové kyseliny a její farmaceutická kompozice |
| MX363389B (es) | 2013-12-12 | 2019-03-20 | Synthon Bv | Composicion farmaceutica que comprende ivabradina amorfa. |
| EP2774606B1 (en) | 2014-02-14 | 2019-01-30 | Synthon B.V. | Pharmaceutical composition comprising ivabradine hydrochloride polymorph IV |
| CZ2014478A3 (cs) | 2014-07-10 | 2015-09-16 | Zentiva, K.S. | Pevná forma Ivabradin hydrochloridu a (R)-mandlové kyseliny a její farmaceutická kompozice |
| WO2016102423A1 (en) | 2014-12-22 | 2016-06-30 | Ratiopharm Gmbh | Composition comprising ivabradine in a dissolved form |
| GR1008821B (el) | 2015-06-11 | 2016-08-01 | Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων | Φαρμακευτικο σκευασμα που περιλαμβανει υδροχλωρικη ιβαμπραδινη και μεθοδος παρασκευης αυτου |
| CN107056706B (zh) * | 2015-12-21 | 2020-05-05 | 江苏恒瑞医药股份有限公司 | 一种用于制备盐酸伊伐布雷定α晶型的方法 |
| TR201703066A2 (tr) | 2017-02-28 | 2018-09-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | İvabradi̇ni̇n kati oral farmasöti̇k kompozi̇syonlari |
| EP3366282A1 (en) | 2017-02-28 | 2018-08-29 | Sanovel Ilac Sanayi ve Ticaret A.S. | Solid oral pharmaceutical compositions of ivabradine |
| IT202000025312A1 (it) | 2020-10-26 | 2022-04-26 | Cambrex Profarmaco Milano S R L | Processi per la preparazione di polimorfi di ivabradina hcl |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3119874A1 (de) * | 1981-05-19 | 1982-12-09 | Dr. Karl Thomae Gmbh, 7950 Biberach | "benzazepinderivate, ihre herstellung und ihre verwendung als arzneimittel" |
| DE3418270A1 (de) * | 1984-05-17 | 1985-11-21 | Dr. Karl Thomae Gmbh, 7950 Biberach | Neue aminotetralinderivate, diese verbindungen enthaltende arzneimittel und verfahren zu ihrer herstellung |
| GB9017453D0 (en) | 1990-08-09 | 1990-09-26 | Mcivor Robert C | Fluid additive regulating apparatus |
| FR2681862B1 (fr) * | 1991-09-27 | 1993-11-12 | Adir Cie | Nouvelles (benzocycloalkyl)alkylamines, leur procede de preparation, et les compositions pharmaceutiques qui les contiennent. |
| FR2868777B1 (fr) * | 2004-04-13 | 2006-05-26 | Servier Lab | Nouveau procede de synthese de l'ivabradine et de ses sels d'addition a un acide pharmaceutiquement acceptable |
| FR2882555B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme cristalline gamma du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2882554B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme critalline beta d du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2882553B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme cristalline beta du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| FR2882556B1 (fr) * | 2005-02-28 | 2007-05-04 | Servier Lab | Forme cristalline gamma d du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent |
| CA2504863A1 (en) * | 2005-04-21 | 2006-10-21 | Larry J. Chernoff | Integrated valve system |
-
2005
- 2005-10-11 FR FR0510352A patent/FR2891826B1/fr not_active Expired - Fee Related
-
2006
- 2006-09-21 CR CR8645A patent/CR8645A/es unknown
- 2006-09-22 MA MA29340A patent/MA28626B1/fr unknown
- 2006-09-27 AP AP2006003762A patent/AP2303A/xx active
- 2006-09-29 SG SG200606818-3A patent/SG131858A1/en unknown
- 2006-10-02 PE PE2006001194A patent/PE20070492A1/es not_active Application Discontinuation
- 2006-10-05 TW TW095137030A patent/TWI377946B/zh not_active IP Right Cessation
- 2006-10-05 GT GT200600450A patent/GT200600450A/es unknown
- 2006-10-09 US US11/544,910 patent/US7358240B2/en not_active Expired - Fee Related
- 2006-10-09 AR ARP060104433A patent/AR056572A1/es not_active Application Discontinuation
- 2006-10-09 CO CO06101549A patent/CO5790166A1/es not_active Application Discontinuation
- 2006-10-09 SA SA06270370A patent/SA06270370B1/ar unknown
- 2006-10-09 ZA ZA200608403A patent/ZA200608403B/xx unknown
- 2006-10-10 NO NO20064596A patent/NO20064596L/no unknown
- 2006-10-10 UA UAA200610731A patent/UA90265C2/ru unknown
- 2006-10-10 WO PCT/FR2006/002265 patent/WO2007042656A1/fr active Application Filing
- 2006-10-10 NZ NZ550435A patent/NZ550435A/en not_active IP Right Cessation
- 2006-10-10 GE GEAP20069654A patent/GEP20094653B/en unknown
- 2006-10-10 EC EC2006006915A patent/ECSP066915A/es unknown
- 2006-10-10 EP EP08009938A patent/EP1956005A1/fr not_active Withdrawn
- 2006-10-10 MY MYPI20064300A patent/MY139508A/en unknown
- 2006-10-10 EA EA200601662A patent/EA010296B1/ru not_active IP Right Cessation
- 2006-10-10 EP EP06291573A patent/EP1775288A1/fr not_active Ceased
- 2006-10-10 KR KR1020060098450A patent/KR20070040311A/ko not_active Application Discontinuation
- 2006-10-10 BR BRPI0604250-3A patent/BRPI0604250A/pt not_active Application Discontinuation
- 2006-10-11 AU AU2006228027A patent/AU2006228027B2/en not_active Ceased
- 2006-10-11 MX MXPA06011766A patent/MXPA06011766A/es active IP Right Grant
- 2006-10-11 CN CNA2006101322296A patent/CN1948292A/zh active Pending
- 2006-10-11 JP JP2006277130A patent/JP2007112796A/ja not_active Withdrawn
- 2006-10-11 CA CA2564367A patent/CA2564367C/fr not_active Expired - Fee Related
- 2006-10-15 IL IL178544A patent/IL178544A/en not_active IP Right Cessation
-
2008
- 2008-02-20 US US12/070,608 patent/US20080161284A1/en not_active Abandoned
-
2009
- 2009-08-27 US US12/583,915 patent/US7867997B2/en not_active Expired - Fee Related
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Legal Events
| Date | Code | Title | Description |
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| FC | Application refused |